Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Prostate Disorders

Treatment

Preoperative pelvic floor physical therapy

Clinical Study ID

NCT06179654

23-1128

Ages > 18
Male

Study Summary

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age: >=18 years of age
Sex: male sex assigned at birth (needs to have a prostate)
BMI: all BMI
Ethnic background: all ethnicities
Medical history: patients scheduled to undergo HoLEP for BPH/LUTS and associatedcomplications (i.e. gross hematuria, retention, etc.).

Exclusion

Exclusion Criteria:

Neurological disorders: patients with a history of a neurologic disorder that couldaffect muscle function, neurogenic bladder, lumbosacral spine pathology
Specific urologic conditions: patients with pre-operative indwelling catheter,urethral stricture greater than 1 centimeter in length or requiringdilation/incision, indwelling ureteral stent
History of pelvic radiation: patient with prior pelvic radiation will be excluded
Patients unable to give consent
Non-English speaking patients given the need for multiple surveys and telephonefollow-ups.

Study Design

Preoperative pelvic floor physical therapy

November 29, 2023

October 31, 2025

Study Description

The incidence of benign prostatic hyperplasia (BPH) in men significantly increases with age and is estimated to impact over 80% of men 70 to 80 years of age. HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms. Compared to other minimally invasive surgical techniques for treatment of BPH, HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability, high efficacy, and low complications rates. However, transient stress urinary incontinence (SUI) following HoLEP may last for several months after surgery and can lead to diminished patient quality of life during the recovery period. Measures to prevent or reduce post-operative SUI following HoLEP, including PFPT, may improve patient outcomes.

SUI is also commonly documented after radical prostatectomy (RP) for prostate cancer. The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter, which is part of the pelvic floor musculature. While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP, there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP.

The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented. To date, only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months. However, the study included patients with a BMI significantly lower than average in the United States, utilized an unclear PFPT program, and had a relatively small median prostate size (~60 mL), which is important as studies have shown that prostate size can affect post-operative incontinence.

We propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP. This study will help determine the role of pre-operative PFPT in the management of HoLEP associated SUI.

Connect with a study center

Cleveland Clinic
Cleveland, Ohio 44195
United States
Active - Recruiting

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